Recovery OutcomesNCT07875829
Quality of Recovery After Colorectal Surgery (Robots vs Laparoscopic)
A study testing Robotic vs laparoscopic surgery in people with Recovery Outcomes, run by Hospital Central do Funchal at 1 site in Portugal.
Trial summary
Minimally invasive techniques for colorectal surgery include standard laparoscopy and robot-assisted laparoscopy. Studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recovery Outcomes
- What is being tested?
- Robotic vs laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePortugal
- Study dates
- 12 Jan 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Elective colorectal resection (laparoscopic or robot-assisted);
- ASA I-III;
- Ability to consent and complete QoR-15;
Who cannot join
- Emergency surgery;
- Concomitant major non-colorectal procedure;
- Severe cognitive impairment;
- Refusal/inability to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Hospital Central do Funchal
Funchal, Madeira
Hospital Central do Funchal Hospital Central do Funchal, 00351 291 705 600, sec.anest@sesaram.pt
About this study
Minimally invasive techniques for colorectal surgery include standard laparoscopy and robot-assisted laparoscopy. Studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Although these parameters are essential and should be measured, they mostly ignore the patient's perspective. Patient-related outcomes can be assessed with tools designed for that purpose, such as the Quality of Recovery-15 (QoR-15) questionnaire.
This single-centre prospective observational cohort study will compare robotic vs laparoscopic colorectal resections with the primary outcome of QoR-15 at 24 hours after surgery, capturing anaesthesia-specific variables to adjust for confounding.
Read the detailed description
- Background and rationale Minimally invasive techniques for colorectal surgery include standard laparoscopy and robot-assisted laparoscopy. Studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Although these parameters are essential and should be measured, they mostly ignore the patient's perspective. Patient-related outcomes can be assessed with tools designed for that purpose, such as the Quality of Recovery-15 (QoR-15) questionnaire. This single-centre prospective observational cohort study will compare robotic vs laparoscopic colorectal resections with the primary outcome of QoR-15 at 24 hours after surgery, capturing anaesthesia-specific variables to adjust for confounding.
- Objectives Primary objective: To compare patient-reported quality of recovery (QoR-15 total score) at 24 hours postoperatively between patients undergoing surgeon-allocated robotic vs laparoscopic colorectal surgery following ERAS protocol. Secondary objectives:
- Compare QoR-15 at PACU discharge and at 48h.
- Compare pain scores, opioid consumption (first 24 and 48 h), PONV rates, PACU time, intraoperative hemodynamic instability events, length of hospital stay, complications (Clavien-Dindo), and 30-day readmission.
- Study design Prospective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is determined by the operating surgeon (non-randomised). The anaesthetist will enrol and collect preop, intraop and postop data. Statistical methods will adjust for confounding (propensity-score methods, multivariable regression, clustering by surgeon).
- Inclusion / exclusion criteria Inclusion: Age ≥ 18 years, scheduled for elective colorectal resection (laparoscopic or robot-assisted), ASA I-III, able to consent and complete QoR-15, included in ERAS pathway. Exclusion: Emergency surgery, concomitant major non-colorectal procedure, severe cognitive impairment, refusal/inability to consent.
- Outcomes and definitions Primary outcome: QoR-15 total score (0-150) at 24 hours after surgery (±4 h window). Secondary outcomes: QoR-15 at PACU, 48/72 h; pain scores; opioid use; PONV; PACU and OR times; intraop hemodynamics; LOS; complications; 30-day readmission.
- Anaesthesia recommendations and recording Standardized induction (propofol, fentanyl, rocuronium), maintenance (TIVA), multimodal analgesia, and antiemetic prophylaxis. All drugs, doses, fluid management, temperature, and monitoring to be recorded.
- Data collection (CRF) Detailed CRF variable list includes baseline demographics, comorbidities, preop QoR-15, surgical and anaesthetic details, intraop events, PACU data, postoperative QoR-15, pain, PONV, complications, and LOS. Use validated QoR-15 translation, time-stamp each administration.
- Sample size and power According to the previous literature, the standard deviation (SD) of the total QoR-15 score in the Portuguese population is 14 [7]. An 8-point difference in the QoR-15 score represents the MCID that defines if the quality of recovery was improved (a positive 8-point difference) or worsened (a negative 8-point difference) [8, 9]. A minimum of 49 patients in each group were obtained (3 = 0.05 and 4 = 0.20). Considering 10% possible losses during the study (dropouts), the final sample constituted 110 patients. Parameters: alpha=0.05, 80% power, MCID 6-10 points, SD 12-22. Formula: n per group = 2 × (Zα/2 + Zβ)^2 × σ^2 / δ^2. Example: For MCID=8, SD=14 → ~49 per group (98 total). Considering ~ 10% added for missing data, final sample is 110 (55 per group). Sample size table attached in appendix.
- Statistical analysis plan Primary: Compare QoR-15 at 24 h using propensity-score matched analysis (linear mixed model adjusting for surgeon). Secondary: IPTW and regression with baseline covariates. Other outcomes analysed with appropriate models (logistic, Cox, etc.). Missing data handled with complete-case or multiple imputation. Sensitivity analyses include subgroups and alternative propensity approaches.
- Bias reduction and limitations Collect rich baseline/intraop data; adjust for surgeon clustering; standardize anaesthesia if possible. Limitations: residual confounding, single-centre generalisability.
- Operational considerations Pilot in first 20-30 patients to confirm SD and feasibility; train staff in CRF and QoR-15 administration; secure de-identified data storage.
- Ethical considerations Ethics approval required. Informed consent from all participants. Privacy and compliance complaint with data governance.
- Appendices QoR-15 questionnaire, Case Report Form (CRF), sample size table, Information leaflet, informed consent form attached.
- Conditions
- Recovery Outcomes
- Being tested
- Robotic vs laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic vs laparoscopic surgeryProcedure or surgery
Prospective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is determined by the operating surgeon (non-randomised). The anaesthetist will enrol and collect preop, intraop and postop data. Statistical methods will adjust for confounding (propensity-score methods, multivariable regression, clustering by surgeon).
| Study group | Role | What they receive |
|---|---|---|
| Prospective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is det | Other | Not described Receives: Procedure: Robotic vs laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Quality of Recovery-15 (QoR-15) total score at 24 hours after surgery (±4 h window).
The total score ranges from 0 (very poor recovery) to 150 (excellent quality of recovery).
Measured: January 2026 - May 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start12 Jan 2026
- Primary completion31 May 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-centre, observational cohort study
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central do Funchal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Isabel Pereira, Hospital Central do Funchal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875829
- Sponsor's protocol ID
- E25151751
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery After Colorectal Surgery (Robots vs Laparoscopic)
- ClinicalTrials.gov ID
- NCT07875829
- Acronym / sponsor ID
- E25151751
- Conditions
- Recovery Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hospital Central do FunchalUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Minimally invasive techniques for colorectal surgery include standard laparoscopy and robot-assisted laparoscopy. Studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Although these parameters are essential and should be measured, they mostly ignore the patient's perspective. Patient-related outcomes can be assessed with tools designed for that purpose, such as the Quality of Recovery-15 (QoR-15) questionnaire.
This single-centre prospective observational cohort study will compare robotic vs laparoscopic colorectal resections with the primary outcome of QoR-15 at 24 hours after surgery, capturing anaesthesia-specific variables to adjust for confounding.
Detailed description
- Background and rationale Minimally invasive techniques for colorectal surgery include standard laparoscopy and robot-assisted laparoscopy. Studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Although these parameters are essential and should be measured, they mostly ignore the patient's perspective. Patient-related outcomes can be assessed with tools designed for that purpose, such as the Quality of Recovery-15 (QoR-15) questionnaire. This single-centre prospective observational cohort study will compare robotic vs laparoscopic colorectal resections with the primary outcome of QoR-15 at 24 hours after surgery, capturing anaesthesia-specific variables to adjust for confounding.
- Objectives Primary objective: To compare patient-reported quality of recovery (QoR-15 total score) at 24 hours postoperatively between patients undergoing surgeon-allocated robotic vs laparoscopic colorectal surgery following ERAS protocol. Secondary objectives:
- Compare QoR-15 at PACU discharge and at 48h.
- Compare pain scores, opioid consumption (first 24 and 48 h), PONV rates, PACU time, intraoperative hemodynamic instability events, length of hospital stay, complications (Clavien-Dindo), and 30-day readmission.
- Study design Prospective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is determined by the operating surgeon (non-randomised). The anaesthetist will enrol and collect preop, intraop and postop data. Statistical methods will adjust for confounding (propensity-score methods, multivariable regression, clustering by surgeon).
- Inclusion / exclusion criteria Inclusion: Age ≥ 18 years, scheduled for elective colorectal resection (laparoscopic or robot-assisted), ASA I-III, able to consent and complete QoR-15, included in ERAS pathway. Exclusion: Emergency surgery, concomitant major non-colorectal procedure, severe cognitive impairment, refusal/inability to consent.
- Outcomes and definitions Primary outcome: QoR-15 total score (0-150) at 24 hours after surgery (±4 h window). Secondary outcomes: QoR-15 at PACU, 48/72 h; pain scores; opioid use; PONV; PACU and OR times; intraop hemodynamics; LOS; complications; 30-day readmission.
- Anaesthesia recommendations and recording Standardized induction (propofol, fentanyl, rocuronium), maintenance (TIVA), multimodal analgesia, and antiemetic prophylaxis. All drugs, doses, fluid management, temperature, and monitoring to be recorded.
- Data collection (CRF) Detailed CRF variable list includes baseline demographics, comorbidities, preop QoR-15, surgical and anaesthetic details, intraop events, PACU data, postoperative QoR-15, pain, PONV, complications, and LOS. Use validated QoR-15 translation, time-stamp each administration.
- Sample size and power According to the previous literature, the standard deviation (SD) of the total QoR-15 score in the Portuguese population is 14 [7]. An 8-point difference in the QoR-15 score represents the MCID that defines if the quality of recovery was improved (a positive 8-point difference) or worsened (a negative 8-point difference) [8, 9]. A minimum of 49 patients in each group were obtained (3 = 0.05 and 4 = 0.20). Considering 10% possible losses during the study (dropouts), the final sample constituted 110 patients. Parameters: alpha=0.05, 80% power, MCID 6-10 points, SD 12-22. Formula: n per group = 2 × (Zα/2 + Zβ)^2 × σ^2 / δ^2. Example: For MCID=8, SD=14 → ~49 per group (98 total). Considering ~ 10% added for missing data, final sample is 110 (55 per group). Sample size table attached in appendix.
- Statistical analysis plan Primary: Compare QoR-15 at 24 h using propensity-score matched analysis (linear mixed model adjusting for surgeon). Secondary: IPTW and regression with baseline covariates. Other outcomes analysed with appropriate models (logistic, Cox, etc.). Missing data handled with complete-case or multiple imputation. Sensitivity analyses include subgroups and alternative propensity approaches.
- Bias reduction and limitations Collect rich baseline/intraop data; adjust for surgeon clustering; standardize anaesthesia if possible. Limitations: residual confounding, single-centre generalisability.
- Operational considerations Pilot in first 20-30 patients to confirm SD and feasibility; train staff in CRF and QoR-15 administration; secure de-identified data storage.
- Ethical considerations Ethics approval required. Informed consent from all participants. Privacy and compliance complaint with data governance.
- Appendices QoR-15 questionnaire, Case Report Form (CRF), sample size table, Information leaflet, informed consent form attached.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-centre, observational cohort study
| Arm | Type | Receives |
|---|---|---|
| Prospective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is det | Other | Procedure: Robotic vs laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Elective colorectal resection (laparoscopic or robot-assisted);
- ASA I-III;
- Ability to consent and complete QoR-15;
Key exclusion criteria (4 listed)
- Emergency surgery;
- Concomitant major non-colorectal procedure;
- Severe cognitive impairment;
- Refusal/inability to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic vs laparoscopic surgeryProspective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is determined by the operating surgeon (non-randomised). The anaesthetist will enrol and collect preop, intraop and postop data. Statistical methods will adjust for confounding (propensity-score methods, multivariable regression, clustering by surgeon). | Procedure or surgery | Prospective, single-centre, observational cohort study. Allocation to robotic vs laparoscopic is det |
Primary outcome
Primary outcome: Quality of Recovery-15 (QoR-15) total score at 24 hours after surgery (±4 h window).
Time frame: January 2026 - May 2027
The total score ranges from 0 (very poor recovery) to 150 (excellent quality of recovery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic vs laparoscopic surgery in people with Recovery Outcomes, run by Hospital Central do Funchal at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana I Pereira (+351 910 832 157, 2502anaisabel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Quality of Recovery-15 (QoR-15) total score at 24 hours after surgery (±4 h window). (time frame: January 2026 - May 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.